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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE
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DEERFIELD IMAGING, INC. IMRIS ORT300 OPERATING ROOM TABLE Back to Search Results
Model Number ORT300
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2019
Event Type  malfunction  
Manufacturer Narrative
The field service engineer observed hydraulic fluid dripping from the hydraulic line that runs to the pressure gauge of the ort300 table.He replaced the or table hydraulic line that runs to the pressure gauge to resolve the issue.
 
Event Description
The customer service engineer was on-site to repair an ort300 table trolley.While inspecting the ort300 table, he observed hydraulic fluid dripping from the belly cover of the table while operating the hydraulic pump.There was no patient involved.
 
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Brand Name
IMRIS ORT300 OPERATING ROOM TABLE
Type of Device
OPERATING ROOM TABLE
Manufacturer (Section D)
DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer (Section G)
IMRIS-DEERFIELD IMAGING, INC.
5101 shady oak road
minnetonka MN 55343 4100
Manufacturer Contact
todd sperling
5101 shady oak road
minnetonka, MN 55343-4100
7632036344
MDR Report Key8447989
MDR Text Key139701929
Report Number3010326005-2019-00004
Device Sequence Number1
Product Code KXJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Remedial Action Repair
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberORT300
Device Catalogue Number114093-000
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2019
Initial Date FDA Received03/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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